Non-dairy formulae

ABSTRACT

The present invention is directed to non-dairy almond based formulae for the preparation of infant or toddler formula or other types of supplemental or functional food.

TECHNOLOGICAL FIELD

This invention is directed to non-dairy almond based formulae for thepreparation of infant or toddler formula or other types of supplementalor functional food.

BACKGROUND

Infant formula is a manufactured food designed and marketed for feedingbabies and infants under 12 months of age, usually prepared forbottle-feeding or cup-feeding from powder (mixed with water) or liquid(with or without additional water). The U.S. Federal Food, Drug, andCosmetic Act (FFDCA) defines infant formula as “a food which purports tobe or is represented for special dietary use solely as a food forinfants by reason of its simulation of human milk or its suitability asa complete or partial substitute for human milk”.

The composition of infant formula is designed to be roughly based on ahuman mother's milk at approximately one to three months postpartum,although there are significant differences in the nutrient content ofthese products. The most commonly used infant formulas contain purifiedcow's milk whey and casein and/or skimmed milk powder as a proteinsource, a blend of vegetable oils as a fat source, lactose as acarbohydrate source, a vitamin-mineral mix, and other ingredientsdepending on the manufacturer.

A 2001 World Health Organization (WHO) report found that infant formulaprepared in accordance with applicable Codex Alimentarius standards wasa safe complementary food and a suitable breast milk substitute.

As most of the infant formulas are based on cow's milk whey and caseinas a protein source, many babies develop allergy or intolerancecondition that may be at times, life threatening.

Cow's milk allergy is a food allergy, an adverse immune reaction to oneor more of the constituents of Cow's milk (most commonly the proteinalpha S1-casein). This milk-induced allergic reaction can involveanaphylaxis, a potentially life-threatening condition.

The principal symptoms are gastrointestinal, dermatological andrespiratory. These can translate to: skin rash, hives, vomiting, andgastric distress such as diarrhea, constipation, stomach pain orflatulence. The clinical spectrum extends to diverse disorders:anaphylactic reactions, atopic dermatitis, wheeze, infantile colic,gastroesophageal reflux (GER), oesophagitis, allergic colitis, headache,oral irritation, and constipation. The symptoms may occur within a fewminutes after exposure in immediate reactions, or after hours (and insome cases after several days) in delayed reactions.

Some babies may develop or are born with lactose intolerance which is anon-allergic food sensitivity, and comes from a lack of production ofthe enzyme lactase, required to digest the predominant sugar in milk.Adverse effects of lactose intolerance generally occur after much higherlevels of milk consumption than do adverse effects of milk allergy. Milkprotein intolerance (MPI) is delayed reaction to a food protein that isnormally harmless to the non-allergic, non-intolerant individual. Milkprotein intolerance produces a non-IgE antibody and is not detected byallergy blood tests. Milk protein intolerance produces a range ofsymptoms very similar to milk allergy symptoms, but can also includeblood and/or mucus in the stool. Treatment for milk protein intoleranceis the same as for milk allergy. Milk protein intolerance is alsoreferred to as milk soy protein intolerance (MSPI).

For formula fed infants, milk substitute formulas are used to provide acomplete source of nutrition. Milk substitutes include soy basedformulas; hypoallergenic formulas based on partially or extensivelyhydrolyzed protein, and free amino acid-based formulas.

Non-milk derived amino acid-based formulas, known as amino acid formulasor elemental formulas, are considered the gold standard in the treatmentof cows milk allergy when the mother is unable to breastfeed.

Hydrolyzed formulas come in partially hydrolyzed and extensivelyhydrolyzed varieties. Partially hydrolyzed formulas (PHFs) arecharacterized by a larger proportion of long chain peptides and areconsidered more palatable. However, they are intended for milder casesand are not considered suitable for treatment of moderate to severe milkallergy or intolerance. Extensively hydrolyzed formulas (EHFs) arecomposed of proteins that have been largely broken down into free aminoacids and short peptides. Casein and whey are the most commonly usedsources of protein in hydrolyzed formulas because of their highnutritional quality and their amino acid composition.

Soy based formula may or may not pose a risk of allergic sensitivity, assome infants who are allergic to milk may also be allergic to soy. Alsosoy based formulas are not recommended for infants under 6 months.

Infant formulas also come in a variety of types:

Cow's milk formula is the most commonly used type (e.g.: Similac,Enfamil).

Soy protein based formulas are frequently used for infants allergic tocow's milk (e.g.: Isomil, ProSobee).

Partially hydrolyzed formulas (e.g.: Good Start and Gentlease brands)are marketed as having improved digestibility.

Extensively hydrolyzed formulas (e.g.: Alimentum, Nutramigen, andPregestimil) are considered “hypoallergenic”. One study reported that90% of children with cow's milk allergies will tolerate them.

Amino acid based formulas (e.g.: Neocate, EleCare, and Nutramigen AA)are more expensive, but are reported least likely to cause allergicreactions.

Hypoallergenic formulas, such as those containing free individual aminoacids, and sometimes referred to as elemental infant formula, areconsidered to reduce the likelihood of certain medical complications inbabies with specific health problems, such as severe allergies to cow'smilk and soy. Made of purely synthetic monomeric amino acids, they areoften considered quite foul-tasting, and it is not uncommon for infantsto reject elemental formulas after having been established on asweeter-tasting regular formula, thus the level of compliance of infantsin an age wherein feeding is crucial, such incompliance is lifethreatening.

SPIFs (Soy Protein Infant Formulae) contain phytoestrogens, mostlyisoflavonoids (particularly diadzein, genistein). It was shown thatthese substances tend to bind to estrogen receptors and behave as pro-or anti-estrogens. The amount of phytoestrogens in SPIF (32-47 mg/liter)is 40 times higher than the amount in breast milk. Consumption ofisoflavonoids from SPIF reaches 11 mg/kg body weight per day, and theirlevels in infant blood were 13,000 to 22,000 times higher than the bloodlevels of estrogen-like substances in the first years of life. Infantswho are fed only on SPIF are exposed to a daily consumption ofisoflavonoids that is 4-13 times the amount presumed to have aphysiological effect on balancing the menstrual cycle in women. Recentlythe scientific literature has raised some concerns regarding the vastconsumption of SPIFs regarding the fact that phytoestrogens could havean adverse effect on infant and child growth (they are not recommendedfor premature infants weighing less than 1800 grams), development andpuberty, bone health and thyroid function. In addition, the fact thatmost of the soy crops are genetically engineered the use of SPIF is notrecommended in certain countries and is regulated to the extent ofrequiring a prescription for administration for infants having severeallergies.

There is therefore a true need in the art for a non-dairy formula forinfants that can provide all essential nutritional needs similar to thegold standard of breast milk nutritional profile without thedisadvantages of currently known non-dairy formula.

GENERAL DESCRIPTION

In the first of its aspects the present invention provides a compositioncomprising almond and at least one non-dairy component comprising allessential amino acids, wherein said composition is a non-dairycomposition for use in the nutrition of an infant and/or a toddler.

In some embodiments of the invention said composition provides anutritional dose for a single feeding portion to an infant and/or atoddler in a dry form (in some embodiments a portion of 9-10 grams readyfor use upon mixing and dissolved with water (in some embodiments aportion of 60 ml, capable of being administered by a feeding bottle,i.e. drinkable hence consistency and viscosity is low). The inventors ofthe present application have found that a composition comprising atleast the above two components provides to an infant or a toddler or asubject in need thereof a regulated nutritional feeding that providesthe necessary proteins, amino-acids, and other nutrients needed for asingle serving of food.

When referring to almond, it should be understood to encompass any typeof almond tree shelled drupe (Prunus dulcis, syn. Prunus amygdalusBatsch., Amygdalus communis L., Amygdalus dulcis Mill), in any type ofform (peeled from seedcoat, unpeeled, ground, powdered, milled and soforth). The almond provides the lipid component of the composition(including, among others the essential linolenic and alpha linolenicacids).

In some aspects of the invention said almond can be replaced with atleast one other nut selected from the following list: brazil nut,candlenut, cashew, Chilean hazelnut, macadamia, Malabar chestnut,mongongo, peanut, pine nut, pistachio, walnut and yeheb nut, or anycombinations thereof with or without almond.

In some embodiments said almond component of a composition of theinvention is pre-treated (i.e. prior to the addition of almond componentto the composition of the invention) to lower the levels (amount) ofphytic acid in said almond. Said pre-treatment of the almond componentis performed by at least one of the following: treatment of almondcomponent with phytase enzyme, soaking of said almond component inwater, heating of almond component, peeling of almond, steaming of saidalmond, bleaching and roasting and any combinations thereof.

Under some embodiments, said reduction or lowering of phytic acid levelsis for the removal of substantially all phytic acid from the almondcomponent of a composition of the invention (i.e. said compositioncomprising no more than 0.001-0.5% wt of phytic acid).

In some embodiments said almond component of a composition of theinvention is pre-treated, prior to its addition to the composition, saidpre-treatment includes, but is not limited to: peeling of almond peel,steaming of said almond, heating, grinding, hydrolyzing, bleaching,roasting and so forth.

In some further embodiments said almond and/or non-dairy componentcomprising all essential amino acids are pre-treatment prior to theirmixture in said composition of the invention for removal of fibers tothe suitable levels for the intended population of subjects to betreated.

The term “non-dairy component” refers to a component of a composition ofthe invention which does not come from any dairy producing animalsource, however comprises all essential amino acids needed for acomposition for the nutrition of an infant, a toddler, an adult or anelderly person.

When referring to “essential amino acids” (or indispensable amino acids)it should be understood to encompass the amino acids that cannot besynthesized de novo by humans, and therefore must be supplied in thediet. In the context of the present application the list of essentialamino acids include histidine, isoleucine, leucine, lysine, methionine,phenylalanine, threonine, tryptophan and valine.

When referring to an “infant” it should be understood to encompass anewborn neonate between the ages of 0 and 1 year old. This term includesboth full term and premature neonates at any body weight.

When referring to a “toddler” it should be understood to encompass ahuman between the ages of 1 and 3 years. This term includes humans inthis age range at any cognitive or health condition.

In the context of the present application when referring to nutrition ofinfants it should be understood to refer to the nourishment of infantsby the use of food compositions that can substantially simulate humanmilk or its suitability as a complete or partial substitute for humanmilk. These food compositions (infant formula) can be used as the solefood source of an infant.

In the context of the present application when referring to nutrition oftoddlers it should be understood to refer to the nourishment of toddlersby the use of food compositions that can provides all requirednutritional values for the age group considering the fact that toddlerfood compositions (toddler formula or follow-on formula or growing upformula) are not the sole food source of a toddler.

In a further aspect the invention provides a composition comprisingalmond and at least one non-dairy component comprising all essentialamino acids, wherein said composition is a non-dairy composition for usein supplementing the nutrition of a subject.

When referring to “supplementation of the nutrition of a subject” itshould be understood to encompass qualitative and quantitativecomplementation of the nutrition of a subject (whether a human infant,toddler, child, adolescent, adult, elderly person at any health orphysical condition) by the necessary recommended nutrients.

In yet another aspect the invention provides a composition comprisingalmond and at least one non-dairy component comprising all essentialamino acids, wherein said composition is a non-dairy infant and/ortoddler formula.

In another aspect the invention provides a composition comprising almondand at least one non-dairy component comprising all essential aminoacids, wherein said composition is a non-dairy functional food formula.

When referring to “functional food formula” it should be understood toencompass a food or nutritional formula that serves to promote thehealth of a subject (in any condition of health, such as for examplehealthy subjects that participate in exercise and training of any kind)and/or prevent/treat/ameliorate at least one disease or a symptomthereof (such as for example bowl diseases, malnutrition diseases,inflammatory diseases, cognitive and neurological diseases,cardiovascular diseases and so forth). Additionally, functional food mayserve to supplement the nutrition of a subject recovering from acondition or disease in need of supplemental nutrients since theircondition does not allow said subject to receive all dietary requiredfor recovery. Functional food may also serve as additional supplementalfood for patient population that are more vulnerable to malnutrition,subjects having lean body mass and declining basal metabolic rate, suchas for example elderly subjects (age 65 and above).

The invention further provides a composition comprising almond and atleast one non-dairy component comprising all essential amino acids,wherein said composition is a non-dairy composition for use in wholebalance nutrition of a subject.

When referring to “whole balance nutrition of a subject” it should beunderstood to encompass the necessary essential ingredients needed by asubject (whether a human infant, toddler, child, adolescent, adult,elderly person at any health or physical condition) to sustain healthand function.

The required nutritional levels, allowed supplements and additionaladditives are typically regulated in each country by the healthauthority responsible for food and drug regulation. Thus, compositionsof the invention may further include any additional components requiredunder each territorial regulation requirements, such as for example:

-   -   US Code of Federal Regulations Title 21, Part 107 (Infant        formula)    -   Dietary reference intake of US National Academy of Sciences.        Institute of Medicine. Food and Nutrition Board    -   European Commission Directive 2006/141/EC

In some embodiments said at least one non-dairy component comprising allessential amino acids further comprises semi-essential amino acids.

In some embodiments said at least one non-dairy component comprising allessential amino acids is a single non-dairy component comprising allessential amino acids.

In other embodiments said at least one non-dairy component comprisingall essential amino acids further comprises carbohydrates.

In other embodiments said at least one non-dairy component comprisingall essential amino acids is pre-hydrolyzed (i.e. prior to addition tothe composition of the invention). This hydrolyzation is performed forthe purpose of hydrolyzing the carbohydrates of said at least onenon-dairy component comprising all essential amino acids (such as forexample buckwheat), thus reducing its viscosity. In some embodiments,said hydrolization of said at least one non-dairy component comprisingall essential amino acids is performed by use of an acid or an enzyme(for example amylase).

In some other embodiments said at least one non-dairy component (such asfor example buckwheat) is pre-gelatinized prior to its addition of acomposition of the invention. This pre-gelatinization process isintended for making the carbohydrates in said non-dairy component to bebiologically available to the subject treated with said composition. Insome embodiments said pre-gelatinization is performed by at least one ofheating, roasting, steaming said at least one non-dairy component priorto its addition to the composition of the invention.

In further embodiments a composition of the invention may includeadditional non-dairy sources of protein and/or fat including but notlimited to pumpkin seeds, sunflower seeds, pinecone seeds, sesame seeds,flax seeds.

In other embodiments said at least one non-dairy component is selectedfrom grain, fabaceae (including but not limited to beans, broad beans,chickpeas, peas, trigonella, caraway and so forth).

In some embodiments, said at least one non-dairy component is at leastone type of grain.

In other embodiments said at least one type of grain is cereal grain orpseudocereal grain.

In some embodiments said almond is pre-treated to lower the level ofphytic acid in said almond component or composition.

In other embodiments the ratio between almond and said at least onenon-dairy component is from about 10:90 to about 90:10.

In other embodiments the ratio between almond and said at least onenon-dairy component is from about 30:70 to about 70:30.

In yet further embodiments, almond is present in an amount of at least10% by weight from the total weight of the composition.

In further embodiments said at least one non-dairy component is presentin an amount of at least 5% by weight from the total weight of thecomposition.

Infant formulas come in powder, liquid concentrate, and ready-to-feedforms. They are designed to be prepared by the parent or caregiver insmall batches and fed to the infant.

In some other embodiments said composition is in the form of a drycomposition. In other embodiments, said composition is in the form of awater soluble dry powder. In other embodiments a composition of theinvention further comprises a liquid. In some embodiments said liquid iswater.

In some embodiments said at least one type of grain is cereal grainselected from the group consisting of maize (corn), rice, wheat, barley,sorghum, millet, oats, triticale, rye, fonio and any combinationsthereof.

In other embodiments, said at least one type of grain is pseudocerealgrain selected from buckwheat, amaranth and quinoa. In some embodimentssaid at least one type of grain is buckwheat. In some furtherembodiments said at least one type of grain is a whole grain.

In some embodiments a composition of the invention further comprises atleast one additive selected from vitamins, minerals, trace elements,carbohydrates, lipids, proteins, probiotic agents (micro-organismswhich, when administered in adequate amounts, confer a health benefit onthe host), prebiotic agents (non-digestible food ingredients thatstimulate the growth and/or activity of bacteria in the digestive systemin ways claimed to be beneficial to health), nucleotides,poly-unsaturated fatty acids, fluoride, choline, and any combinationsthereof (as required by the above noted Codex).

In other embodiments a composition of the invention further comprises atleast one additive selected from nucleotides, poly-unsaturated fattyacids, fluoride, choline and any combinations thereof (as required bythe above noted Codex).

In other embodiments a composition of the invention further comprises atleast one additive selected from a flavoring agent, an oil protectivecolloid, a plasticizer, an antioxidant, a pro-biotic agent, a pre-bioticagent, an emulsifier, a thickener, an acidity regulator, a packaging gasand any combinations thereof (as required by the above noted Codex).

In some embodiments, said at least one additive is between about 0.001%to about 5% by weight of composition.

In some embodiments a composition of the invention is an infant ortoddler formula.

In other embodiments a composition of the invention is an adultnutritional supplemental formula.

The invention further provides a process for the preparation of aformulation comprising the steps of: (a) mixing almond with at least onenon-dairy component; (b) adding water to the mixture obtained in step(a) to obtain a suspension; (c) drying the suspension obtained in step(b), thereby obtaining a dry composition.

In some embodiments of a process of the invention the ratio between thealmond and the said at least one non-dairy component is from about 10:90to about 90:10.

In some embodiments of a process of the invention the ratio between thealmond and the said at least one non-dairy component is from about 30:70to about 70:30.

In other embodiments a process of the invention further comprises addingto the mixture obtained in step (a) from about 0.001% to about 5% of atleast one additive.

In other embodiments of a process of the invention drying is by beddrying, drum drying, freeze drying, shelf dryers or spray drying.

In some embodiments said at least one non-dairy component is hydrolizedprior to said mixing in step (a). In some other embodiments, said atleast one non-dairy component is pre-treated prior to said mixing instep (a) with at least one of: grinding, steaming, roasting, heating,bleaching, peeling, hydrolization (enzymatic, using for example amylase,or chemical hydrolyzation) or any combination thereof.

In other embodiments said almond is treated for lowering (reducing orremoving) the levels of phytic acid prior to said mixing in step (a). Insome other embodiments, said almond is pre-treated prior to said mixingin step (a) with at least one of: grinding, steaming, heating,bleaching, roasting, peeling, removal of phytic acid (enzymatic, usingfor example phytase or a chemical removal of the acid) or anycombination thereof.

In some embodiments said almond and/or non-dairy component are treatedprior to said mixing in step (a) by at least one of peeling (for exampleof shell of said component), steaming, heating, gelatinization (alsoknown as pre-gelatinization), griniding, hydrolyzing (for example usingenzymes), bleaching, roasting and any combinations thereof.

In some other embodiments said at least one non-dairy component (such asfor example buckwheat) is pre-gelatinized prior to step (a) of a processof the invention.

In some embodiments a composition of the invention comprises between30-60 wt % (in some embodiments 45% wt) almonds, 20-50% wt (in someembodiments 33% wt) buckwheat, 10-30% wt (in some embodiments 20% wt)maltodextrine, 0.5-10% wt (in some embodiments 5% wt) mineral andvitamins, 0.5-10% wt (in some embodiments 5% wt) fatty acids (such asfor example LCPUFA). In some other embodiments, said composition is adry composition ready to be used upon dissolving in water or any otherliquid (such as for example milk, almond milk, soy milk, fruit juice andso forth). In some further embodiments said composition dose is betweenabout 5 to 15 grams capable of being dissolved in 50 to 60 ml of liquidto produce a drinkable feeding portion (i.e. a feeding portion thatprovides a single serving portion for the nutrition of a subject that isflowing to the extent that it can be administered through a feedingbottle or a feeding device). Feeding dose 8-15 times.

Example 1

I. Almond Component

-   -   a. Almonds are pasteurized during drying in two steps: (a) in        the slurry before the drum dryer. (72 C, 40 sec) and (b) on the        drum dryer as part of the pre gelatinized.    -   b. Reduction of the phytic acid content is performed by        marinating and washing the almond component or by using phytase        enzyme (process is controlled by heating the slurry to        inactivate the phytase enzyme).    -   c. Bleaching the almond component.

II. Buckwheat Component

-   -   a. The buckwheat should be pre gelatinized in order to be        available for babies' consumption. The pre gelatinized process        causes a high viscosity when the powder is mixed with water.    -   b. The buckwheat can be hydrolyzed with enzymes (such as for        example Amylase) in order to reduce its viscosity. The        hydrolization process gives an ability to control fiber content        to the levels required.    -   c. The hydrolyzed process is taken place when the buckwheat is        dissolved with water before drum drying.    -   d. Amylase is added to the solution at 30-37 C.    -   e. The enzyme is inactivated by raising the temperature to above        50 C.

III. Production Process

-   -   a. The Buckwheat is mixed in water.    -   b. Heat the slurry to 37 C.    -   c. Add and mix the enzymes.    -   d. The slurry heated up to 55 C in order to inactivated the        enzymes activity    -   e. Add to the hydrolizated buckwheat and mix all other        ingredients, that are: almonds, minerals, vitamins.    -   f. Feed the slurry to the drum dryer.    -   g. Drying conditions    -   h. Dry mixing stage: with reactive metals Zn, Cu, Mg.

The invention claimed is:
 1. A method of supplementing the nutrition ofan adult subject comprising administering to said subject a composition,comprising: a) an almond component that has been treated to reduce thephytic acid content; and b) at least one a single non-dairy componentcomprising all essential amino acids; wherein said at least onenon-dairy component comprising all essential amino acids is at least onea type of grain that has been pre-hydrolyzed or pre-gelatinized; whereinsaid adult subject is vulnerable to malnutrition, having lean body massand declining basal metabolic rate; and wherein said compositionprovides the necessary proteins, amino-acids, and other nutrients neededin a single serving of food.
 2. A method according to claim 1, whereinsaid at least one non-dairy component comprising all essential aminoacids further comprises semi-essential amino acids.
 3. A methodaccording to claim 1, wherein said at least one non-dairy componentcomprising all essential amino acids further comprises carbohydrates. 4.A method according to claim 1, wherein said at least one type of grainis cereal grain or pseudocereal grain.
 5. A method according to claim 1,wherein the ratio between almond and said at least one non-dairycomponent is from about 10:90 to about 90:10.
 6. A method according toclaim 1, wherein the almond is present in an amount of at least 10% byweight from the total weight of the composition.
 7. A method accordingto claim 1, wherein said at least one non-dairy component is present inan amount of at least 5% by weight from the total weight of thecomposition.
 8. A method according to claim 1, wherein at least one typeof grain is pseudocereal grain selected from buckwheat, amaranth orquinoa.
 9. A method according to claim 1, wherein said at least one typeof grain is buckwheat.
 10. A method according to claim 1, wherein atleast one type of grain is a whole grain.
 11. A method according toclaim 1, further comprising at least one additive selected fromvitamins, minerals, trace elements, carbohydrates, lipids, proteins andany combinations thereof.
 12. A method according to claim 1, furthercomprising at least one additive selected from nucleotides,poly-unsaturated fatty acids, fluoride, choline, a probiotic agent,prebiotic agent, and any combinations thereof.
 13. A method according toclaim 1, further comprising at least one additive selected from aflavoring agent, an oil protective colloid, a plasticizer, anantioxidant, an emulsifier, a thickener, an acidity regulator, apackaging gas and any combinations thereof.
 14. A method according toclaim 1, wherein the composition comprises no more than 0.5% wt ofphytic acid.
 15. A method according to claim 1, wherein the compositioncomprises no more than 0.001% wt of phytic acid.